MAUDE Adverse Event Report: ZEST ANCHORS, LLC LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI); ENDOSSEOUS DENTAL IMPLANT

Model Number	07501-S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Non-integration.Dr yost called in (b)(6) 2023 that his lodi implants did not have osseo-integration on one pt.Dr placed 6 lodis on (b)(6) 2023, they started failing 3 weeks later and by (b)(6) 2023 they were all out.Dr did not have reference numbers or lot numbers.He provided me implant specs and i am inputting my educated guess on ref and lot numbers in the notes section below.
Event or Problem Description
Non-integration.Doctor (b)(6) called in (b)(6) 2023 that his lodi implants did not have osseo-integration on one patient.Dr placed 6 lodis on (b)(6), they started failing 3 weeks later and by (b)(6) they were all out.Doctor did not have reference numbers or lot numbers.He provided me implant specs and i am inputting my educated guess on ref and lot numbers in the notes section below.

• Brand Name: LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): ZEST ANCHORS, LLC; 2875 loker ave east; carlsbad 92010
• Manufacturer (Section G): ZEST ANCHORS, LLC; 2875 loker ave east; carlsbad 92010
• Manufacturer Contact: amie toor ; 2875 loker ave e; carlsbad, CA 92010
• MDR Report Key: 16773190
• Report Number: 2023950-2023-00126
• Device Sequence Number: 12335383
• Product Code: DZE
• UDI-Device Identifier: 00840481130762
• UDI-Public: 00840481130762
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K120198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 07501-S
• Device Catalogue Number: N/A
• Device Lot Number: L297K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Congenital Anomaly
• Patient Sex: Unknown